Clinical improvement after Essure® devices removal: a systematic review.

PURPOSE: Essure® implant is a permanently implanted minimally invasive birth control device for women (female sterilisation) widely used between 2002 and 2018. Many adverse events were reported by patients. Increasingly removal procedures have been performed in symptomatic patients. However, there is a lack of in-depth studies on clinical improvement after Essure® removal. We aimed to review all clinical studies about symptoms and quality of life (QoL) after removal procedures. MATERIALS AND METHODS: A review of literature in electronic search in Medline and Embase databases from January 2002 to January 2022 using the following keywords: Essure; Essure removal; quality of life; symptomatology improvement. RESULTS: Out of 764 articles in the initial database, 18 clinical studies were eligible for inclusion in our literature review. Overall clinical improvement rates after removal ranged from 21% to 98%. All symptoms were less frequent after Essure® removal, although with large discrepancies between studies. Lack of improvement was reported between 1% to 15% of patients. Rate of patients with improvement of QoL after removal ranged from 58 to 98%. The pain was reported as significantly reduced after the surgery. CONCLUSIONS: In the available literature, Essure® removal in symptomatic patients may improve symptoms and quality of life. This should be discussed in the benefits and risks ratio before deciding on the best option of management.

Essure® removal in symptomatic patients may improve symptoms and quality of life.

Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure® implant removal: a cross-sectional study.

PURPOSE: Many concerns have been raised about adverse effects related to Essure® device. Several pathophysiological hypotheses have been proposed including allergic reactions, Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants, galvanic corrosion with release of heavy metals and inflammation. In the present study, we aimed to focus on inflammation process by performing a histopathological evaluation of Fallopian tubes in symptomatic patients with Essure® removal. MATERIALS AND METHODS: A cross-sectional study with identification of the type of inflammatory response and characterisation of inflammatory cells in the surrounding tubal tissue around the Essure® (STTE) and at distance from the implant. Histopathological and clinical correlations were also investigated. RESULTS: In the STTE from 47 cases, acute inflammation was observed in 3/47 (6.4%) cases. Chronic inflammation with lymphocytes (42.5%, 20/47) was associated with a significant higher pre-operative pain score (p = .03). Fibrosis was noted in 43/47 (91.5%) cases. Fibrosis without lymphocytes (51.1%, 24/47) was statistically associated with significant reduced pain (p = .04). At distance from the Essure® implant, only chronic inflammation with lymphocytes was present in 10/47 (21.7%) cases. CONCLUSIONS: Inflammation response do not seem to be enough to explain all the Essure-related adverse outcomes, suggesting the involvement of other biological mechanisms. CLINICALTRIALS.GOV IDENTIFIER: NCT03281564.

Inflammation and fibrosis are found in the surrounding tubal tissue around the Essure^®. Inflammation process alone doesn't seem to be enough to explain symptomatology.

How to be sure of a complete removal of Essure® implant? A radiological study of Essure® microinserts.

PURPOSE: Laparoscopic cornuectomy, one of the most performed surgical techniques to remove Essure® implants, is associated with a risk of fragmentation of the device. We aimed to assess the diagnostic accuracy of the intraoperative radiograph of the removed Essure® microinserts compared with intraoperative inspection of the device. STUDY DESIGN: In this French retrospective cohort study including 66 patients, two experienced gynecologists and two residents evaluated the intraoperative radiograph in a blind manner. Diagnostic accuracy was calculated for each observer. RESULTS: The global sensitivity and specificity for intraoperative radiograph to detect a residual fragment for both senior gynecologists and residents were, respectively 87.5 % (±3.3) and 80.0 % (+/12.2). Pooled positive (PPV) and negative predictive values (NPV) for intraoperative radiograph were respectively 99.2 % (±0.5) and 21.6 % (±6.4). There was a statistically significant difference in intraoperative radiograph analysis between senior gynecologists and residents (sensitivity: 91.4 %±0.8 vs 79.6 %±1.5, p = 0.02; specificity: 100% vs 50.0 %, p < 0.0001; PPV: 100 % vs 98.0 % ±0.1, p = 0.0007; NPV: 26.8 % ±1.8 vs 7.2 % ±0.5, p = 0.009). Sensitivity and specificity of the intraoperative inspection of the removal specimen was respectively 95.3 % and 100 % (PPV and NPV were, respectively 100 and 40 %). There were no statistically significant differences in diagnostic accuracy between intraoperative radiographs analysis and intraoperative inspection of the device for the senior gynecologists. CONCLUSIONS: Intraoperative radiograph of the removed Essure® implants analysis is a difficult skill needing specific training. Postoperative pelvic X-ray is still recommended in clinical practice after laparoscopic cornuectomy.

Plasma and peritoneal fluid cytokine profiles in patient with Essure® implant: Towards a molecular signature?

OBJECTIVE(S): Many patients with Essure® implant may experience adverse events related to the device. Although local inflammation does not appear to be the pathophysiological mechanism underlying the symptoms, systemic inflammation could play a role. In the present study, as cytokines are involved in the inflammatory process, we proposed to investigate the profile of circulating and peritoneal cytokines. STUDY DESIGN: In this retrospective study, we evaluated the levels of cytokines in peritoneal fluid (PF) as well as in plasma sample from three different groups: Essure® group, endometriosis group (known to be associated with immune dysregulation), and control group. RESULTS: There were 60 symptomatic patients with Essure® device, 30 patients with endometriosis and a control group of 30 patients. The PF levels of Interleukin-10 (IL-10), Interleukin-6 (IL-6), and Monocyte chemoattractant protein-1 (MCP-1) were statistically higher in endometriosis group than in Essure® group and control group. The plasma level of MCP-1 was higher in Essure® group than in endometriosis group and control group. The plasma level of TNF-α was higher in Essure® group than in control group. CONCLUSIONS: The chemokine MCP-1 as well as the pro-inflammatory TNF-α, are known to be increased in patients with fibromyalgia and chronic fatigue syndrome. Since patients with Essure® may exhibit symptoms similar to fibromyalgia, MCP-1 and TNF-α may be relevant markers in symptomatic patients with Essure®. Because of the lack of longitudinal data (no evaluation of postoperative cytokine profile and no assessment of the level of clinical improvement), other studies are needed to confirm these preliminary results.